MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	6530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter city:.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of an 8mm x 3.00mm nc quantum apex balloon catheter, it was noted that the shaft was broken.The procedure was completed with a 3mmx8mm non-boston scientific balloon.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).Device evaluated by mfr.: media provided by the customer was reviewed and shows shaft separation.Returned product consisted of an nc quantum apex mr 8mm x 3.00mm catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and blood in the balloon.Balloon was identified with tight folds.Separation was identified at shaft 56.8 cm from the strain relief and prolapse tip was identified.Product analysis confirms the reported event as shaft break was confirmed 56.8 cm from strain relief.Although the reported event stated that time of event was after opening device, contrast was found in inflation lumen and blood in the balloon, which indicates device was prepped and/or likely used in procedure.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of an 8mm x 3.00mm nc quantum apex balloon catheter, it was noted that the shaft was broken.The procedure was completed with a 3mmx8mm non-boston scientific balloon.No patient complications were reported and the patient status was stable.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15103929
• Report Number: 2124215-2022-25739
• Device Sequence Number: 14482187
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2024
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0028149692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: Asian